Recruiting

SOMA

Sponsor:

Brown University

Code:

NCT05754190

Conditions

Chronic Pain

Acute Pain

Post Operative Pain

Fibromyalgia, Primary

Fibromyalgia, Secondary

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

SOMA pain manager smartphone application

Study Details

Brief summary:

This study relies on the use of a smartphone application (SOMA) that the investigators developed for tracking daily mood, pain, and activity status in acute pain, chronic pain, and healthy controls over four months.The primary goal of the study is to use fluctuations in daily self-reported symptoms to identify computational predictors of acute-chronic pain transition, pain recovery, and/or chronic pain maintenance or flareups. The general study will include anyone with current acute or chronic pain, while a smaller sub-study will use a subset of patients from the chronic pain group who have been diagnosed with chronic low back pain, failed back surgery syndrome, or fibromyalgia. These sub-study participants will first take part in one in-person EEG testing session while completing simple interoception and reinforcement learning tasks and then begin daily use of the SOMA app. Electrophysiologic and behavioral data from the EEG testing session will be used to determine predictors of treatment response in the sub-study.

Conditions

Chronic Pain

Acute Pain

Post Operative Pain

Fibromyalgia, Primary

Fibromyalgia, Secondary

Study ID

NCT05754190

Start date

Jun 20, 2023

Status verified date

Sep, 2025

Completion date

May 30, 2026

Anticipated

Primary completion date

May 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

INCLUSION CRITERIA \[General study\]

  • Chronic pain group:

  • Age above 18
  • Access to a personal smartphone and a stable internet connection
  • Average pain intensity score of greater than 3 in the past week or
  • Average pain interference score of greater than 3 in the past week or
  • Average pain distress score of greater than 3 in the past week
  • Pain duration: greater than 6 months
  • Acute pain group:

  • Age above 18
  • Access to a personal smartphone and a stable internet connection
  • Average pain intensity score of greater than 3 in the past week

○ or
  • Average pain interference score of greater than 3 in the past week

○ or
  • Average pain distress score of greater than 3 in the past week
  • Pain duration: less than 3 months
  • Pain cause: Due to recent surgery, injury, acute illness, or childbirth (within the past 3 months)
  • Healthy control group:

  • Age above 18
  • Access to a personal smartphone and a stable internet connection
  • Average pain intensity score of less than 3 in the past week
  • Average pain interference score of less than 3 in the past week
  • Average pain distress score of less than 3 in the past week
  • No surgery, injury, acute illness, or childbirth (within the past 3 months)
  • In person EEG testing \[Sub-Study only\]:

  • Same as in General App Study Above and additionally:
  • Current diagnosis of Fibromyalgia, Chronic Low Back Pain or Failed Back Surgery Syndrome OR
  • No current or prior history of chronic pain
  • If participant has chronic low back pain or failed back surgery syndrome: are they planning to have either a radio-frequency ablation, back surgery, or spinal cord stimulation implant in the next few months
  • If participant has chronic low back pain or failed back surgery syndrome: have they received insurance approval for the procedure?
  • Ok with EEC/ECG measures

EXCLUSION CRITERIA \[General study\]

  • Chronic pain group:

  • recent injury or surgery unrelated to the pain in the past 3 months
  • difficulty participating for technical/logistical issues (e.g., no computer, incompatible smartphone, can't commit to 4 months study participation);
  • Not fluent in English (difficulty understanding questions)
  • Current primary or metastatic cancer (organic cause of pain)
  • Acute pain group:

  • History of Chronic Pain (Pain lasting for more than 6 months)
  • difficulty participating for technical/logistical issues (e.g., no computer, incompatible smartphone, can't commit to 4 months study participation);
  • Not fluent in English (difficulty understanding questions)
  • Current primary or metastatic cancer (organic cause of pain)
  • Healthy control group:

History of Chronic Pain (Pain lasting for more than 6 months)

  • difficulty participating for technical/logistical issues (e.g., no computer, incompatible smartphone, can't commit to 4 months study participation);
  • Not fluent in English (difficulty understanding questions)

-In person EEG testing \[Sub-study only\]: \[will interfere with EEG data collection safety or quality\]:
  • Same as in General App Study Above and additionally:
  • Baldness
  • Pregnancy
  • Dreadlocks
  • Left-handedness
  • Use of a wheelchair
  • Heart failure diagnosis
  • Current or prior experience with acute psychosis or mania
  • implanted pacemaker, neurostimulator or any other head or heart implants
  • require a hearing aid to hear properly
  • claustrophobia
  • metal fragments in the body

Study Design

Enrollment

800 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy Controls

\[general study + sub study\] No history of chronic pain

Acute pain

\[general study\] Pain duration < 3 months

Chronic pain

\[general study\] Pain duration > 6 months

\[sub-study\] diagnosis of chronic low back pain, failed back surgery syndrome, or fibromyalgia

Interventions

SOMA pain manager smartphone application

SOMA is a smartphone application developed for acute and chronic pain patients to track daily mood and pain symptoms and overall activity.

Primary outcome measure

  • [General Study] Acute-Chronic Pain Transition Probability [ Time Frame: T1 [4 months of daily app use] ]

Central Contacts and Locations

Central contacts

Frederike H Petzschner, PhD

401-863-6272frederike_petzschner@brown.edu

Chloe S Zimmerman, MD/PhD student

401-863-6272chloe_zimmerman@brown.edu

Locations

Brown University

Recruiting

Providence, Rhode Island, United States, 02912

Contacts

Frederike H Petzschner, PhD

401-863-6272frederike_petzschner@brown.edu

Chloe S Zimmerman, MD/PhD Student

401-863-6272chloe_zimmerman@brown.edu

Principal Investigator:

Frederike H Petzschner, PhD

More Information

Sponsor

Brown University

Last update posted

Sep 19, 2025

Last verified

Sep, 2025

Keywords

  • digital health
  • e-health
  • smartphone application
  • chronic pain
  • acute pain
  • symptom tracking
  • experience sampling methodology
  • ecological momentary assessment
  • pain self-management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Brown University on 2025-09-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.